FDA researchers discuss ways to improve the use of AI/ML in precision medicine.
Corvus Pharmaceuticals seeks a 3rd quarter meeting with FDA to discuss a Phase 3 trial for its investigational cancer drug CPI-818.
Harvard Medical School professor Jerry Avorn says FDA needs to take a nonbinary approach to some drug approvals with a conditional approval for margin...
FDA clears a Phase 3 protocol amendment to allow a time-based analysis of Glycomimetics uproleselan if sufficient survival events for an event-driven ...
Public Citizens Health Research Group urges FDA to not grant accelerated approval to Sarepta Therapeutics gene therapy SRP-9001 for treating ambulator...
FDA clears an American Laboratory Products 510(k) for its Calprotectin Immunoturbidimetric Assay as an aid in diagnosing inflammatory bowel disease.
FDA issues a partial clinical hold against Mersana Therapeutics clinical trials of UpRi (upifitamab rilsodotin) in platinum-sensitive ovarian cancer.
Aldeyra Therapeutics says the Phase 3 INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis met...
